Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women

Not Applicable

• Conditions: Insulin Resistance; Postmenopausal
• Interventions: Dietary Supplement: vitamin C (500 mg / day) + placebo; Dietary Supplement: resveratrol (500 mg / day) + placebo; Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day)

• Registration Number: NCT03090997
• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Brief Summary

Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease

Detailed Description

Currently, there are not studies that demonstrate an efficient antioxidant therapy in postmenopausal women, to increase the total antioxidant capacity and to decrease insulin resistance and biochemical parameters of cardio-metabolic risk. Therefore, the aim of this study is to evaluate the effect of the co-administration of resveratrol and vitamin C on insulin resistance and antioxidant capacity by a double-blind randomized clinical trial. A population of 270 postmenopausal women will be studied, stratified into 3 groups:

Group 1: Three-month administration of vitamin C 500 mg daily + placebo Group 2: Three-month administration of resveratrol 500 mg daily + placebo Group 3: Three months administration of vitamin C 500 mg daily and resveratrol 500 mg daily as antioxidant therapy.

All participants will be monitored monthly for a period of 3 months: glucose, insulin, uric acid, Homeostatic Model Assessment (HOMA), total cholesterol (TC), triglycerides (TGC), High density lipoproteins-cholesterol (HDL- C), low density lipoproteins-cholesterol (LDL), blood pressure, body mass index (BMI). The antioxidant efficiency in erythrocytes by the quantification of antioxidant enzymes (superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase), as well as total antioxidant capacity in plasma. In order to corroborate the oxidative damage, the product of the lipoperoxidation malondialdehyde and the carbonylation of proteins will be evaluated by spectrophotometric techniques before and three months after the intervention.

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2018-02-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-24
• Last Update Posted: 2021-12-28
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Women diagnosed with early postmenopause according to STRAW classification.
• Insulin resistance determinated by HOMA ≥ 2.5.
• Not use of metformin, bezafibrates and / or statins, three months before enter to the study
• No indication of hormone replacement therapy.
• Sign the informed consent.

Exclusion Criteria

• Women who present pathologies such as: Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney disease during the course of the study.
• Women who during the development of the protocol require hormone replacement therapy.
• Any type of surgical intervention during the following of the study.
• That the patient wishes to withdraw from the study.
• That the patient does not complete with 80% of adherence to the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	vitamin C (500 mg / day) + placebo	vitamin C (500 mg/day/orally) + placebo
Group 2	resveratrol (500 mg / day) + placebo	resveratrol (500 mg/day/orally) + placebo
Group 3	vitamin C (500 mg / day) and resveratrol (500 mg / day)	vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally)

Primary Outcome Measures

Name	Time	Method
Insulin resistance	HOMA at 3 months after starting the intervention in each group	Insulin resistance measured by HOMA (Homeostatic Model Assessment)

Secondary Outcome Measures

Name	Time	Method
Superoxide dismutase activity	three months after starting the intervention	Enzymatic activity measured by spectrophotometry
Catalase activity	three months after starting the intervention	Enzymatic activity measured by spectrophotometry
Glutathione peroxidase activity	three months after starting the intervention	Enzymatic activity measured by spectrophotometry
Glutathione reductase activity	three months after starting the intervention	Enzymatic activity measured by spectrophotometry
Malondialdehyde	three months after starting the intervention	Enzymatic activity measured by spectrophotometry
Carbonylation of proteins	three months after starting the intervention	Marker of oxidative stress measured by spectrophotometry

Trial Locations

Locations (1)

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes; 🇲🇽 Mexico City, Mexico